All industry funded projects must be electronically submitted to the Office of Sponsored Programs (OSP) at
Industry submissions to OSP must include all applicable, required documents to ensure an accurate and efficient review. The documents required for any given submission depend upon the type of project to be reviewed. A listing of the required documents for each type of submission can be found in the OSP Required Documents Search Tool. A brief description of the required documents is also listed below.
If a submission to OSP is missing any required documents, all required documents should be submitted to
Required Documents for Industry Funded Submissions
Jump to a Section
- Proposals
- Clinical Trials
- Registry Studies
- Observational Studies
- Chart Reviews
- Research Agreements
- Services Agreements
- Data Use Agreements (DUA)
- Project Master Agreements (PMA)
- No Cost Extensions (NCE)
- Amendments
Proposals
UAB Extramural Support Checklist
The UAB Extramural Support Checklist and its corresponding instructions can be found here. The checklist must be submitted to OSP at
For Continuing Medical Education (CME) proposals, the UAB Extramural Support Checklist must be signed by the applicable dean.
Responsible Personnel List
The Responsible Personnel List (RPL) must be submitted to OSP in order for the Office of the Conflict of Interest Review Board (OCIRB) to review disclosures of financial interests from each person who is planning to participate in, or is participating in: (1) a sponsored project and/or (2) a protocol submitted to the Institutional Review Board (IRB) if that person is responsible for the design, conduct or reporting of work. Instructions for completing the RPL may be found here. The RPL document may be found here.
Statement/Scope of Work
The most current draft or final statement of work must be submitted to OSP and is necessary for an accurate review of the proposal. Each project has unique components which must be addressed in the submission, and the statement of work is necessary for the officer or specialist to identify those components. The statement of work also assists the OSP officer or specialist to ensure no discrepancies exist between the submission and corresponding statement of work. The statement of work should be specific and detailed to enable the sponsor to fully understand the proposed work to be funded.
For Continuing Medical Education (CME) proposals, the statement of work or a description of the CME event, including the offered CME credit and supporting documentation, must be submitted to OSP.
Budget
The most current draft of the budget must be submitted to OSP. While the final budget is not necessary at the time of submission, it is necessary for inclusion into the final award. Thus, the final budget should be provided to the OSP officer or specialist as soon as it is available. Please ensure the applicable Facilities and Administration (F&A) rate is included in the budget pursuant to the rate agreement or UAB policy.
Funding Announcement/Website
The funding announcement and/or website link must be submitted to OSP for all proposal submissions. This information must be included on the UAB Extramural Support Checklist or in the submission email to OSP if no website is available. The funding announcement and website provides necessary information regarding an industry sponsor’s requirements and guidelines for submitting the proposed project to the sponsor. The funding announcement and website also provides any terms and conditions that may be applicable to the receipt of awarded funds.
Miscellaneous Required Documents (if applicable)
For Continuing Medical Education (CME) proposals, the application or approval letter from CME must be submitted to OSP.
If applicable to the proposal, any additional sponsor required documentation must be submitted to OSP. Additionally, if applicable to the proposal, a statement of intent and/or cover letter must be submitted to OSP.
Clinical Trials/Registry Studies/Observational Studies/Chart Reviews
UAB Extramural Support Checklist
The UAB Extramural Support Checklist and its corresponding instructions can be found here. The checklist must be submitted to OSP at
Responsible Personnel List
The Responsible Personnel List (RPL) must be submitted to OSP in order for the Office of the Conflict of Interest Review Board (OCIRB) to review disclosures of financial interests from each person who is planning to participate in, or is participating in: (1) a sponsored project and/or (2) a protocol submitted to the Institutional Review Board (IRB) if that person is responsible for the design, conduct or reporting of work. Instructions for completing the RPL may be found here. The RPL document may be found here.
Protocol or Statement/Scope of Work
The final protocol or statement of work must be submitted to OSP and is necessary for an accurate review of the agreement. Each project has unique components which must be addressed in the agreement, and the protocol or statement of work is necessary for the officer or specialist to identify those components. The protocol or statement of work also assists the OSP officer or specialist to ensure no discrepancies exist between the agreement and corresponding protocol or statement of work. Further, submission of the final protocol or statement of work is necessary to enable the OSP officer or specialist to incorporate the document as an exhibit to the agreement.
The statement of work must be specific and detailed to include all deliverables, timeframes and milestones applicable to the project. Statements of work must also include a detailed payment schedule describing the means and frequency that payments will be issued, as well as to whom and to where payments will be received for the project. A template statement of work may be found here.
Informed Consent Form/HIPAA Authorization
The most current or final draft of the informed consent form must be submitted to OSP. The informed consent has information related to risk, subject medical injury and use of personal health information that may correspond with language in the agreement and assists the officer or specialist with tailoring the terms of the agreement appropriately.
Budget
The most current draft of the budget must be submitted to OSP for all projects that will receive monetary funding from an external industry source. While the final budget is not necessary at the onset of the negotiation, it is necessary for final processing of the award. Thus, the final budget should be provided to the OSP officer or specialist as soon as it is available. Please ensure the applicable Facilities and Administration (F&A) rate is included in the budget pursuant to the rate agreement or UAB policy.
Budgets are not required for non-sponsored funded projects. Non-sponsor funded projects include projects in which an external industry source provides only product, material, and/or equipment, including drug(s) and/or device(s), for the performance of a project and does not provide any monetary funding. Additionally, Facilities and Administration (F&A) rates and costs are not applicable to projects that will not receive monetary funding from an external industry source (see Non-Sponsor Funded Research).
Contract/Agreement
The OSP officer or specialist will need an unlocked, editable copy of the agreement (including applicable exhibits, attachments, appendices, etc.), in Word version or format, which must be included with a submission to OSP. The Principal Investigator (PI) and the corresponding department should review the agreement prior to submission to OSP and provide any comments or areas of concern in an email or memorandum to your assigned OSP officer or specialist. Please do not make edits or comments in the agreement provided by the industry sponsor.
Hospital Letter of Agreement
(Medical Device Trials Only)
A Hospital Letter of Agreement must be submitted to OSP for Category B device trials only. Because these letters often take time to receive, it is recommended the Principal Investigator (PI) begin this process upon or before submission to OSP. The Clinical Billing Review (CBR) unit will assist in determining whether a Hospital Letter of Agreement is necessary.
Research Agreements and Services Agreements
UAB Extramural Support Checklist
The UAB Extramural Support Checklist and its corresponding instructions can be found here. The checklist must be submitted to OSP at
Responsible Personnel List
The Responsible Personnel List (RPL) must be submitted to OSP in order for the Office of the CIRB to review disclosures of financial interests from each person who is planning to participate in, or is participating in: (1) a sponsored project and/or (2) a protocol submitted to the Institutional Review Board (IRB) if that person is responsible for the design, conduct or reporting of work. Instructions for completing the RPL may be found here. The RPL document may be found here.
Statement/Scope of Work
The final statement of work must be submitted to OSP and is necessary for an accurate review of the agreement. Each project has unique components which must be addressed in the agreement, and the statement of work is necessary for the officer or specialist to identify those components. The statement of work also assists the OSP officer or specialist to ensure no discrepancies exist between the agreement and corresponding statement of work. Further, submission of the final statement of work is necessary to enable the OSP officer or specialist to incorporate the document as an exhibit to the agreement.
The statement of work must be specific and detailed to include all deliverables, timeframes and milestones applicable to the project. Statements of work must also include a detailed payment schedule describing the means and frequency that payments will be issued, as well as to whom and to where payments will be received for the project. A template statement of work may be found here.
Budget
The most current draft of the budget must be submitted to OSP for all projects that will receive monetary funding from an external industry source. While the final budget is not necessary at the onset of the negotiation, it is necessary for final processing of the award. Thus, the final budget should be provided to the OSP officer or specialist as soon as it is available. Please ensure the applicable Facilities and Administration (F&A) rate is included in the budget pursuant to the rate agreement.
Budgets are not required for non-sponsored funded projects. Non-sponsor funded projects include projects in which an external industry source provides only product, material, and/or equipment, including drug(s) and/or device(s), for the performance of a project and does not provide any monetary funding. Additionally, Facilities and Administration (F&A) rates and costs are not applicable to projects that will not receive monetary funding from an external industry source (see Non-Sponsor Funded Research).
Contract/Agreement
The OSP officer or specialist will need an unlocked, editable copy of the agreement (including applicable exhibits, attachments, appendices, etc.), in Word version or format, which must be included with a submission to OSP. The Principal Investigator (PI) and the corresponding department should review the agreement prior to submission to OSP and provide any comments or areas of concern in an email or memorandum to your assigned OSP officer or specialist. Please do not make edits or comments in the agreement provided by the industry sponsor.
Data Use Agreements, Project Master Agreements, No-Cost Extensions, and Amendments
UAB Expedited Checklist
Please see our dedicated DUA page.
The UAB Expedited Checklist must be submitted to OSP when submitting any of the following: No-Cost Extensions (NCE), Project Master Agreements (PMA), and Data Use Agreements (DUA). Because these agreements do not involve funding, the departmental signatures and attestations are not required. Please note the UAB Expedited Checklist may only be used to process amendments that do not add additional funding to a project and/or that do not change the Principal Investigator (PI) of a project. Please also note No-Cost Extensions may only be processed for agreements that do not contain a specified project end date. The UAB Expedited Checklist may be found here.
Please note for submissions to OSP requiring the UAB Expedited Checklist, a Responsible Personnel List (RPL) is also required but only when the submission involves a change of responsible personnel for a project. For additional information, see the UAB Conflict of Interest Policy and the RPL Instructions.
Contract/Agreement
The OSP officer or specialist will need an unlocked, editable copy of the agreement (including applicable exhibits, attachments, appendices, etc.), in Word version or format, which must be included with a submission to OSP. The Principal Investigator (PI) and the corresponding department should review the agreement prior to submission to OSP and provide any comments or areas of concern in an email or memorandum to your assigned OSP officer or specialist. Please do not make edits or comments in the agreement provided by the industry sponsor.
Statement/Scope of Work (Data Use Agreements Only)
For Data Use Agreements (DUA) only, the final statement of work must be submitted to OSP and is necessary for an accurate review of the agreement. Each project has unique components which must be addressed in the agreement, and the statement of work is necessary for the officer or specialist to identify those components. The statement of work also assists the OSP officer or specialist to ensure no discrepancies exist between the agreement and corresponding statement of work. Further, submission of the final statement of work is necessary to enable the OSP officer or specialist to incorporate the document as an exhibit to the agreement.
The statement of work must be specific and detailed to include all deliverables, timeframes and milestones applicable to the project. A template statement of work may be found here.